Pharmaceutical Raw Material Testing
Analysis of various raw materials to Pharmacopoeia Specifications. Typical tests usually include Identification tests, Assay, Related Substances, Heavy Metals, Sulphated Ash etc.
The testing of Pharmaceutical raw materials is usually to asses one of the following; identity, purity, quality, potency, toxicity or efficacy.
GMP Regulations and ICH Guidelines require raw materials and their suppliers to be validated both initially and periodically. It is the legal responsibility of the pharmaceutical manufacturer for the raw materials it uses. Raw material validation should be part of GMP procedures. Changes to systems, raw material suppliers, change of purpose of the finished product or scale up in the factory should all require validations of the raw materials used
If the customer purchases pharmaceutical raw materials from their suppliers and they come in multiple drums / containers they regularly require full monograph testing on a composite sample and Identification testing only on the individual drums / containers.
Pharmaceutical raw material testing requires a wide range of analytical chemistry expertise and a wide variety of instrumentation, both of which we have in the ILS Pharmaceutical Chemistry Testing Laboratory.
Contact ILS - for any further information raw materials testing